BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS PENILE PROSTHESIS

    MDR report key: 1031608 · Received April 17, 2008

    Report

    Report Number
    MW5006296
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 17, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING PENILE PROSTHESIS PUMP. DATES OF USE: 2006-2008. DIAGNOSIS OR REASON FOR USE: ED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS PENILE PROSTHESIS 800 ACCESSORY PENILE PROSTHESIS PUMP FHW AMERICAN MEDICAL SYSTEMS, INC 800 462366010

    Patients

    Seq Age Sex Outcome Treatment
    1